Congress shields rare-disease drugs from Medicare price negotiation
S. 3019 — No Big Blockbuster Bailouts Act · Filed by Peter Welch (D-VT) · 2 cosponsors · Introduced Oct 21, 2025 · Referred to committee
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What it does
This bill exempts orphan drugs (medications for rare diseases) from Medicare's drug price negotiation program by raising their eligibility threshold from $200 million to $400 million in annual sales. Only drugs meeting the higher threshold can be negotiated; orphan drugs stay protected from price negotiation, preserving higher prices for rare-disease treatments starting in 2028.
Why we flagged it
The bill's operative mechanism is a targeted exemption for orphan drugs from Medicare price negotiation, achieved by doubling the sales threshold. This is a direct financial protection for pharmaceutical manufacturers of rare-disease treatments, not a public-health measure.
What the text implies
- The $400M threshold may capture drugs beyond true orphan-drug status if a manufacturer structures indications narrowly; the bill does not limit the number of rare conditions a drug can treat, only that ALL approved indications must be rare.
- Delayed application (2028 start) allows current orphan drugs to remain negotiated under existing rules for 3+ years, then grandfathers them out—creating a cliff that may incentivize manufacturers to seek orphan designation before the cutoff.
The full analysis lists 3 implications of this text.
Who stands to gain
pharmaceutical manufacturers of orphan drugs; biotech companies with rare-disease pipelines